Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Radiofrequency (RF) energy is a commonly used surgical tool that has been used for tissue ablation and more recently for tissue remodeling. For example, RF energy has been investigated as a treatment of gastroesophageal reflux disease (GERD), ie, the Stretta® procedure, in which RF lesions are designed to alter the biomechanics of the lower esophageal sphincter, in orthopedic procedures to remodel the joint capsule, or in an intradiscal electrothermal annuloplasty (IDET) procedure, in which the treatment is intended in part to modify and strengthen the disc annulus. In all of these procedures, nonablative levels of RF thermal energy are used to alter collagen fibrils, which results in a healing response characterized by fibrosis. Recently, RF energy has been explored as a minimally invasive treatment option for fecal incontinence.

Fecal incontinence is the involuntary leakage of stool from the rectum and anal canal. Fecal continence depends on a complex interplay of anal sphincter function, pelvic floor function, stool transit time, rectal capacity, and sensation. There are a variety of etiologies, including injury from vaginal delivery, anal surgery, neurologic disease, and the normal aging process. It is estimated that the disorder affects 8% of the adult population. Medical management includes dietary measures, such as the addition of bulk-producing agents to the diet and elimination of foods associated with diarrhea. Antidiarrheal drugs can be used for mild degrees of incontinence. Bowel management programs, commonly used in patients with spinal cord injuries, may also be effective in patients with fecal incontinence. Biofeedback has been investigated as well. Surgical approaches primarily include a sphincteroplasty, although more novel approaches may be attempted in those patients whose only other treatment option is the creation of a stoma. These novel approaches include an artificial anal sphincter or sacral neuromodulation. RF energy has also been investigated as a minimally invasive treatment of fecal incontinence, a procedure referred to as the Secca procedure. In this outpatient procedure using conscious sedation, RF energy is delivered to the sphincteric complex of the anal canal to create discrete thermal lesions. Over several months, these lesions heal and the tissue contracts, changing the tone of the tissue and potentially improving continence.

Regulatory Status

In 2002, the Secca™ System received U.S. Food and Drug Administration (FDA) clearance through the 510(k) process with the following labeled indication:

“The Secca™ System is intended for general use in the electrosurgical coagulation of tissue and is intended for use specifically in the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.”(1) FDA product code: GEI

Policy

Transanal radiofrequency therapy is considered investigational as a treatment of fecal incontinence.

Policy Guidelines

The Secca procedure may be performed on an outpatient basis using conscious sedation and a local anesthetic.

Effective in 2012, there is a specific CPT category III code for this procedure:

0288T: Anoscopy, with delivery of thermal energy to the muscle of the anal canal (eg, for fecal incontinence)

Prior to 2012, there were no specific CPT codes describing this procedure. It was likely that CPT code 46999 (unlisted procedure, anus) would have been used.

Benefit ApplicationBlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

Rationale

This policy was originally created in 2003 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period through August 19, 2014. Following is the summary of the key literature to date.

No trials allowing comparison of outcomes of transanal radiofrequency (RF) treatment of fecal incontinence to available alternative treatments have been identified. The literature search to date has identified 8 nonrandomized studies on this procedure; 7 studies published between 2003 and 2010, and one study published in 2012.

Abbas et al. (2012) published results of their retrospective review of 27 patients who underwent the Secca™ procedure over a 6-year period (2004-2010) at Kaiser Permanente Los Angeles Medical Center.(2) Thirty-one procedures were performed for moderate to severe fecal incontinence. The majority of study patients were women with a mean age of 64 years, and the most common cause of the incontinence was obstetrical injury. Median length of symptoms was 3 years. Biofeedback had failed in more than half of patients, and more than 20% of patients had previous surgical intervention to treat the incontinence. No major complications occurred following the Secca™ procedure, and minor complications were observed in 5 patients (19%; anal bleeding in 4 and swelling of the vulva in 1). A treatment response was noted in 21 patients (78%) (mean Cleveland Clinic Florida Fecal Incontinence [CCF-FI] Score: 16 [baseline] and 10.9 [3 months postoperatively]). Previous studies have suggested that a CCF-FI of greater than 9 indicates a significant impairment of quality of life. (3) However in the study by Abbas et al. only 6 patients (22%) had a sustained long-term response without any additional intervention, and 14 patients (52%) underwent or are awaiting additional intervention for persistent or recurrent incontinence over a mean follow-up period of 40 months.

In 2003, Efron et al published an open-label, single-arm, nonrandomized study of 50 patients who underwent the Secca procedure and were followed-up for 6 months.(4) Patients served as their own controls. The study assessed change in fecal incontinence symptom scores and quality of life between baseline and follow-up. Fecal incontinence was assessed with the CCF-FI score, and quality of life was assessed with the Fecal Incontinence Quality of Life (FIQL) score. Both the CCF-FI and FIQL scores improved in a steady gradual manner over a 6-month period, from 14.6 to 11.1 for the CCF-FI and from 2.5 to 3.1 for the FIQL. Of 44 patients who had an initial baseline CCF-FI score greater than 9, a total of 15 (34%) achieved CCF-FI less than 10 at 6 months. Improvement also was assessed using the Medical Outcomes Study Short Form-36, focusing on mental and social parameters. Mean social function subscore improved from 64.3 to 34.4, and mental health subscore improved from 65.8 to 73.8. Fourteen- day diary data demonstrated significant improvement in all 9 parameters; for example, days with any fecal incontinence dropped from 10 in a 14-day period to 7. In contrast, there were no differences in objective measures of anal sphincter function, ie, there were no differences in manometry measures, rectal sensation volumes, pudendal nerve motor latency, or internal or external sphincter defects, as noted on endoanal ultrasound. The authors noted that determining the mechanism of action for the procedure was not an objective of the study. Three significant procedure-related complications occurred during the trial. Two patients developed anal ulceration, and 1 developed bleeding from a hemorrhoidal vein. Twenty-six minor adverse events occurred, including minor bleeding in 5 patients, transient worsening of incontinence in 4 patients, and anal pain in 5 patients.

Felt-Bersma et al (2007) published results of an uncontrolled study on the Secca procedure in 11 women with fecal incontinence who underwent baseline and posttreatment testing.(5) Six patients (55%) reported improvement; Vaizey Incontinence Questionnaire scores improved 13%, but no changes were observed in anal manometry, rectal compliance measurement, or 3-dimensional anal ultrasound. Postoperative pain was reported to be slight in 8 patients (73%), moderate in 2, and severe in 1. Investigators suggested that this procedure merited further testing and noted that a randomized, controlled trial was underway. Lam et al (2014) reported 3-year outcomes of this cohort plus 20 other patients who underwent the Secca procedure for fecal incontinence.6 Of the total cohort of 31 patients, 5 (16%) maintained a clinically significant response (defined as ≥50% reduction in Vaizey score) for 6 months, 3 (10%) maintained response for 1 year, and 2 (6%) maintained response for 3 years. Improvements from baseline in anal manometry (increased anorectal pressures or enhanced rectal compliance) were not observed.

Ruiz et al (2010) reported on 1-year quality of life and continence outcomes for a series of 24 patients treated with RF energy for fecal incontinence between 2003 and 2004.7 Twelve-month results were available for 16 patients (67%). Mean CCF-FI score improved from 15.6 at baseline to 12.9 at 12 months (p=0.035). Mean FIQL Questionnaire score improved in all subsets except for the depression subscore. The authors comment that the actual clinical significance of this improvement needs to be determined.

Three additional very small case series (n=15, 19, 8) were performed outside the United States.8-10 In 2 of these small trials, no clear benefit was noted for the procedure. Given the small number of studies that have been conducted and the limitations of those trials (ie, small number of patients, lack of control arm and randomization, inconsistencies with inclusion and exclusion criteria, short-term follow-up), efficacy of RF therapy for fecal incontinence is not supported in the literature.

Ongoing and Unpublished Clinical TrialsA search of ClinicalTrials.gov did not identify any clinical trials of RF treatment of fecal incontinence.

Summary of EvidenceStudies described in this policy include a small number of patients, and estimates of treatment differences are very imprecise. Study follow-up periods are variable and need to be considerably longer in larger numbers of patients to properly evaluate long-term outcomes. No new studies on this procedure have been published since the last update; 3-year follow-up of a small cohort of patients showed decrement in response over time. Multicenter randomized controlled trials with sufficient power are required to evaluate the continuing use of this procedure as an alternative to other surgical interventions or physical therapies or as an adjunct treatment option for fecal incontinence. Given the insufficient evidence available to evaluate the impact of the technology on net health outcome, this surgical procedure is considered investigational.

Practice Guidelines and Position StatementsThe United Kingdom’s National Institute for Health and Care Excellence (NICE) issued guidance on RF treatment for fecal incontinence in 2011.(11)NICE concluded that “evidence on endoscopic radiofrequency therapy of the anal sphincter for [fecal] incontinence raises no major safety concerns. There is evidence of efficacy in the short term, but in a limited number of patients. Therefore, this procedure should only beused with special arrangements for clinical governance, consent and audit or research.”(11)

The American Society of Colon and Rectal Surgeons, in their 2007 practice parameters for the treatment of fecal incontinence, classified the Secca™ procedure as a potentially useful treatment intervention for selected patients with moderate fecal incontinence.12 This statement was based on level IV evidence (grade of recommendation C) because of the limited data available on this treatment modality.

U.S. Preventive Services Task Force RecommendationsRF treatment of fecal incontinence is not a preventive service.

Medicare National CoverageThere is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

National Institute for Health and Clinical Excellence (NICE). Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence (2011). Available online at: http://www.nice.org.uk/nicemedia/live/13047/54501/54501.pdf. Last accessed August 2013.